Type 2 Diabetes Mellitus (T2DM)NCT07832409
Cranberry Proanthocyanidins and Lactobacilli for Recurrent UTI Prevention in Type 2 Diabetes
A study testing Cranberry Proanthocyanidins and Lactobacilli in people with Type 2 Diabetes Mellitus (T2DM) and Recurrent Urinary Tract Infections, run by National Institute of Endocrinology, Georgia at 1 site in Georgia.
Trial summary
The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Recurrent Urinary Tract Infections
- What is being tested?
- Cranberry Proanthocyanidins and Lactobacilli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGeorgia
- Study dates
- 10 Sep 2025to 18 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 40 to 75 years.
- Established diagnosis of type 2 diabetes mellitus for >= 12 months.
- Baseline glycated hemoglobin (HbA1c) between 6.5% and 10.0%.
- Documented history of recurrent urinary tract infections (>= 2 episodes in the preceding 12 months or >= 1 episode in the preceding 6 months).
- Absence of active symptomatic UTI at enrollment, verified by screening urine analysis and culture.
- Maintained on stable glucose-lowering therapy for at least 3 months prior to enrollment.
- Willing and able to comply with the 60-day supplementation and 180-day follow-up protocol.
- Provided written informed consent.
Who cannot join
- Active, symptomatic urinary tract infection at the time of screening.
- Known anatomical or functional urinary tract abnormalities (e.g., neurogenic bladder, urinary tract obstruction, indwelling catheter).
- Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or end-stage renal disease.
- Severe hepatic impairment or active malignancy.
- Routine use of systemic antibiotic prophylaxis for UTI within 30 days prior to screening.
- Regular intake of cranberry-containing supplements, D-mannose, or commercial probiotic formulations within 30 days prior to enrollment.
- Known allergy or hypersensitivity to cranberry extracts, proanthocyanidins, or any excipient in the study formulation.
- Pregnancy, lactation, or women planning pregnancy during the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Potency Cranberry Proanthocyanidins and Lactobacilli for Recurrent Urinary Tract Infection Prevention in Women With Type 2 Diabetes: A Prospective Single-Arm Feasibility Study
The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes mellitus and a documented history of recurrent urinary tract infections (rUTIs).
Participants received a 60-day active intervention consisting of a combined capsule taken twice daily, followed by a 120-day observation period without study intervention, for a total follow-up duration of 180 days. Primary feasibility outcomes included screening and enrollment metrics, retention rate at day 180, and tolerability/adverse event rates. Exploratory endpoints included the incidence of microbiologically confirmed symptomatic UTIs and changes in antibiotic prescription rates compared with pre-enrollment history.
Read the detailed description
Women with type 2 diabetes mellitus (T2DM) are disproportionately affected by recurrent urinary tract infections due to glucosuria, impaired innate immune defenses, and urogenital dysbiosis, which is often compounded by the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors.
This prospective, open-label, single-arm feasibility study was conducted at the National Institute of Endocrinology in Tbilisi, Georgia. Eligible participants were women aged 40 to 75 years with established T2DM (HbA1c 6.5%-10.0%) and a confirmed history of recurrent UTIs (defined as >=2 episodes in the prior 12 months or >=1 in the prior 6 months) without active infection at enrollment.
The study protocol comprised:
- Screening window: up to 14 days to confirm eligibility and baseline stability.
- Active intervention phase: 60 consecutive days of oral supplementation with a commercial capsule containing 72 mg of standardized cranberry PACs and 2x10^9 CFU of a multi-strain Lactobacillus formulation (L. rhamnosus, L. acidophilus, L. casei) taken twice daily with meals (total 144 mg PACs daily).
- Observation phase: 120 days of prospective follow-up without study supplementation.
Standard glucose-lowering therapies (including metformin and SGLT2 inhibitors) were maintained unchanged throughout the 180-day study. The study was designed to generate operational, safety, and preliminary signal data to inform the sample size calculation and methodological design of a future randomized, double-blind, placebo-controlled clinical trial.
- Being tested
- Cranberry Proanthocyanidins and Lactobacilli
- Keywords
- Type 2 diabetes, Recurrent urinary tract infection, Proanthocyanidins, Lactobacillus, Feasibility study, SGLT2 inhibitors
- Medical subject headings
- Diabetes Mellitus, Type 2, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry Proanthocyanidins and LactobacilliDietary supplement
Also called Cranberry PACs + Probiotic formulation
Oral capsule containing 72 mg of standardized cranberry proanthocyanidins (PACs) and 2x10^9 CFU multi-strain Lactobacillus (L. rhamnosus, L. acidophilus, L. casei), administered twice daily with meals for 60 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active Supplementation Arm | Experimental | Participants received oral capsules containing standardized cranberry proanthocyanidins (72 mg) and multi-strain Lactobacillus (2x10^9 CFU) twice daily for 60 consecutive days, followed by a 120-day observation phase. Receives: Dietary Supplement: Cranberry Proanthocyanidins and Lactobacilli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Completion and Retention Rate
Proportion of enrolled participants who successfully completed the entire 180-day protocol (comprising the 60-day active supplementation phase and the 120-day observation phase) without premature discontinuation.
Measured: Day 180
Secondary outcomes (3)
Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)
Number of microbiologically confirmed symptomatic UTI episodes (presence of acute urinary symptoms accompanied by significant bacteriuria >= 10^3 to 10^5 CFU/mL) recorded per participant during the 180-day evaluation period.
Measured: Day 1 to Day 180
Frequency of Antibiotic Courses Prescribed for UTI
Total number of systemic antibacterial treatment courses initiated for acute symptomatic urinary tract infections during the 180-day study period.
Measured: Day 1 to Day 180
Incidence of Treatment-Emergent Adverse Events
Incidence, severity, and causality assessment of adverse events reported during the active supplement period, with particular focus on gastrointestinal tolerability (e.g., dyspepsia, nausea, abdominal discomfort).
Measured: Day 1 to Day 60 (active intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start10 Sep 2025
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single-arm feasibility design. All enrolled participants received the active dietary supplement intervention for 60 days, followed by a 120-day observation period.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Endocrinology, Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shota Janjgava, MD, PhD, Principal investigator, National Institute of Endocrinology, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832409
- Sponsor's protocol ID
- NIE-T2D-UTI-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article will be made available upon reasonable request to qualified academic researchers for scientific verification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Potency Cranberry Proanthocyanidins and Lactobacilli for Recurrent Urinary Tract Infection Prevention in Women With Type 2 Diabetes: A Prospective Single-Arm Feasibility Study
- ClinicalTrials.gov ID
- NCT07832409
- Acronym / sponsor ID
- NIE-T2D-UTI-01
- Keywords
- Type 2 diabetes, Recurrent urinary tract infection, Proanthocyanidins, Lactobacillus, Feasibility study, SGLT2 inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Endocrinology, GeorgiaUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes mellitus and a documented history of recurrent urinary tract infections (rUTIs).
Participants received a 60-day active intervention consisting of a combined capsule taken twice daily, followed by a 120-day observation period without study intervention, for a total follow-up duration of 180 days. Primary feasibility outcomes included screening and enrollment metrics, retention rate at day 180, and tolerability/adverse event rates. Exploratory endpoints included the incidence of microbiologically confirmed symptomatic UTIs and changes in antibiotic prescription rates compared with pre-enrollment history.
Detailed description
Women with type 2 diabetes mellitus (T2DM) are disproportionately affected by recurrent urinary tract infections due to glucosuria, impaired innate immune defenses, and urogenital dysbiosis, which is often compounded by the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors.
This prospective, open-label, single-arm feasibility study was conducted at the National Institute of Endocrinology in Tbilisi, Georgia. Eligible participants were women aged 40 to 75 years with established T2DM (HbA1c 6.5%-10.0%) and a confirmed history of recurrent UTIs (defined as >=2 episodes in the prior 12 months or >=1 in the prior 6 months) without active infection at enrollment.
The study protocol comprised:
- Screening window: up to 14 days to confirm eligibility and baseline stability.
- Active intervention phase: 60 consecutive days of oral supplementation with a commercial capsule containing 72 mg of standardized cranberry PACs and 2x10^9 CFU of a multi-strain Lactobacillus formulation (L. rhamnosus, L. acidophilus, L. casei) taken twice daily with meals (total 144 mg PACs daily).
- Observation phase: 120 days of prospective follow-up without study supplementation.
Standard glucose-lowering therapies (including metformin and SGLT2 inhibitors) were maintained unchanged throughout the 180-day study. The study was designed to generate operational, safety, and preliminary signal data to inform the sample size calculation and methodological design of a future randomized, double-blind, placebo-controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single-arm feasibility design. All enrolled participants received the active dietary supplement intervention for 60 days, followed by a 120-day observation period.
| Arm | Type | Receives |
|---|---|---|
| Active Supplementation Arm | Experimental | Dietary Supplement: Cranberry Proanthocyanidins and LactobacilliParticipants received oral capsules containing standardized cranberry proanthocyanidins (72 mg) and multi-strain Lactobacillus (2x10^9 CFU) twice daily for 60 consecutive days, followed by a 120-day observation phase. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 40 to 75 years.
- Established diagnosis of type 2 diabetes mellitus for >= 12 months.
- Baseline glycated hemoglobin (HbA1c) between 6.5% and 10.0%.
- Documented history of recurrent urinary tract infections (>= 2 episodes in the preceding 12 months or >= 1 episode in the preceding 6 months).
- Absence of active symptomatic UTI at enrollment, verified by screening urine analysis and culture.
Key exclusion criteria (8 listed)
- Active, symptomatic urinary tract infection at the time of screening.
- Known anatomical or functional urinary tract abnormalities (e.g., neurogenic bladder, urinary tract obstruction, indwelling catheter).
- Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or end-stage renal disease.
- Severe hepatic impairment or active malignancy.
- Routine use of systemic antibiotic prophylaxis for UTI within 30 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry Proanthocyanidins and LactobacilliAlso: Cranberry PACs + Probiotic formulationOral capsule containing 72 mg of standardized cranberry proanthocyanidins (PACs) and 2x10^9 CFU multi-strain Lactobacillus (L. rhamnosus, L. acidophilus, L. casei), administered twice daily with meals for 60 consecutive days. | Dietary supplement | Active Supplementation Arm |
Primary outcome
Study Completion and Retention Rate
Time frame: Day 180
Proportion of enrolled participants who successfully completed the entire 180-day protocol (comprising the 60-day active supplementation phase and the 120-day observation phase) without premature discontinuation.
3 secondary outcomes
Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)
Time frame: Day 1 to Day 180
Frequency of Antibiotic Courses Prescribed for UTI
Time frame: Day 1 to Day 180
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 60 (active intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article will be made available upon reasonable request to qualified academic researchers for scientific verification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shota Janjgava, MD, PhD principal investigator
National Institute of Endocrinology, Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Proanthocyanidins and Lactobacilli in people with Type 2 Diabetes Mellitus (T2DM) and Recurrent Urinary Tract Infections, run by National Institute of Endocrinology, Georgia at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Completion and Retention Rate (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.